The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
Primary Purpose
Burn Scar
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fractional Vascular Laser
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar focused on measuring burn, scar, laser, fractional, vascular
Eligibility Criteria
Inclusion Criteria:
- living in Winnipeg
- burn scar 6-12 months old
- Fitzpatrick skin type I-III
- thermal burn scar on trunk or extremities
Exclusion Criteria:
- open wound
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Proximal
Distal
Arm Description
location of the scar proximal to heart
location of scar distal to heart
Outcomes
Primary Outcome Measures
reduction in scar appearance
examine with modified Vancouver Scar Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01619917
Brief Title
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
Official Title
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our assessing the effects of fractional vascular lasers on burn scars. It has been hypothesized that the fractional vascular lasers work on mature scars to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. The retexturing/ resurfacing of the laser theoretically can decrease the visibility of the mesh pattern created by meshed split thickness skin graft).
Objective:
To determine the benefit of fractional vascular laser treatment in improving burn scar height, texture, vascularity and pliability in late burn scars.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
Keywords
burn, scar, laser, fractional, vascular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proximal
Arm Type
Active Comparator
Arm Description
location of the scar proximal to heart
Arm Title
Distal
Arm Type
Experimental
Arm Description
location of scar distal to heart
Intervention Type
Device
Intervention Name(s)
Fractional Vascular Laser
Intervention Description
laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
Primary Outcome Measure Information:
Title
reduction in scar appearance
Description
examine with modified Vancouver Scar Scale
Time Frame
every 3 weeks to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
living in Winnipeg
burn scar 6-12 months old
Fitzpatrick skin type I-III
thermal burn scar on trunk or extremities
Exclusion Criteria:
open wound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S Logsetty, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Role of Fractional Vascular Laser Therapy in the Management of Burn Scars
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